IN.PACT® Admiral® – PACLITAXEL-COATED PTA BALOON CATHETER
Now FDA-Approved
IN.PACT Admiral Drug-Coated Balloon
Finally, an SFA Standard.
list-bullet INCOMPARABLE CLINICAL OUTCOMES IN THE SFA
IN.PACT Admiral demonstrates positive, consistent outcomes across a broad range of patient populations.
list-bullet PROVEN PRIMARY THERAPY IN SFA DISEASE
IN.PACT Admiral has demonstrated a low provisional stenting rate, minimizing the need for durable implants.
list-bullet DIFFERENTIATED DCB DESIGN INTENDED TO MAXIMIZE SAFETY AND EFFICACY
95.7% primary safety composite, proving superior safety to standard PTA.
Lowest Reported Reintervention Rate Offers Best-in-Class Patient Outcomes while Reducing Healthcare System Costs


12-Month Reported CD-TLR Rates Weighted Average
Learn More
list-bullet For further information on Medtronic Peripheral products,
visit peripheral.medtronicendovascular.com
Defined as freedom from device and procedure-related death at 30 days and freedom from target limb major amputation and CD-TVR at 12 months.

†† Comprehensive list of cited publications on file with Medtronic.

UC201502581 EN © Medtronic, Inc. 2014. All rights reserved. For distribution in the USA only. 12/14
Indications for Use:
The IN.PACT Admiral Paclitaxel-Coated PTA Balloon catheter is indicated for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.

Contraindications
The IN.PACT Admiral DCB is contraindicated for use in:
Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries
Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
Patients with known allergies or sensitivities to paclitaxel
Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

Warnings
Use the product prior to the Use-by Date specified on the package.
Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened.
Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation medium (equal parts contrast medium and saline solution).
Do not move the guidewire during inflation of the IN.PACT Admiral DCB.
Do not exceed the rated burst pressure (RBP). The RBP (14 atm [1419 kPa]) is based on the results of in vitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection.
The safety and effectiveness of implanting multiple IN.PACT Admiral DCBs with a total drug dosage exceeding 20,691 µg of paclitaxel in a patient has not been clinically evaluated in the IN.PACT SFA Trial.

Precautions
This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA).
This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
Assess risks and benefits before treating patients with a history of severe reaction to contrast agents.
Potential interactions of the IN.PACT Admiral DCB with alternative therapies such as drug-eluting stents, lasers, atherectomy, cryoplasty, cutting/scoring balloons, and brachytherapy have not been evaluated and should be avoided whenever possible.
The extent of the patient’s exposure to the drug coating is directly related to the number of balloons used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content.
The use of this product carries the risks associated with percutaneous transluminal angioplasty, including thrombosis, vascular complications, and/or bleeding events.

Potential Adverse Events
Adverse events that may occur or require intervention include, but are not limited to the following: abrupt vessel closure; access site pain; allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm; arterial thrombosis; arteriovenous (AV) fistula; death; dissection; embolization; fever; hematoma; hemorrhage; hypotension/hypertension; inflammation; ischemia or infarction of tissue/organ; local infection at access site; local or distal embolic events; perforation or rupture of the artery; pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated artery; sepsis or systemic infection; shock; stroke; systemic embolization; vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are not limited to the following: balloon rupture; detachment of a component of the balloon and/or catheter system; failure of the balloon to perform as intended; failure to cross the lesion.

Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy.

Refer to the Physician’s Desk Reference for more information on the potential adverse events observed with paclitaxel. There may be other potential adverse events that are unforeseen at this time.

Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse events. This content is available electronically at www.manuals.medtronic.com

CAUTION: Federal (USA) law restricts the use of this device to sale by or on the order of a physician.
Medtronic Vascular, Inc.
3576 Unocal Place
Santa Rosa, CA 95403
USA
Product Services
Support Center
Tel: 888.283.7868
Fax: 800.838.3103 USA
CardioVascular LifeLine
Customer Support
Tel: 877.526.7890
Tel: 763.526.7890